The NHS has embarked on a journey to become one of the safest healthcare systems in the world as part of the next steps on the NHS Five Year Forward View.
NHS England has a statutory duty to ensure that safe systems are in place for the management and use of controlled drugs. This is to prevent harm to patients and staff from any misuse of controlled drugs.
Controlled Drugs are drugs that are subject to high levels of regulation as a result of government decisions about those drugs that are especially addictive and harmful.
This page contains links to resources that will be of use to healthcare professionals who work with controlled drugs.
Our statutory duty
In 2007, The Controlled Drugs (Supervision of Management and Use) Regulations 2006 were introduced as part of the Government’s response to the Shipman Inquiry’s Fourth Report that was published in 2004; the regulations were updated in 2013.
Controlled Drugs (CDs) are essential to modern clinical care. The aim of the regulations is to strengthen the governance arrangements for the use and management of controlled drugs. It is essential that NHS England enforces robust arrangements for the management and use of CDs to minimise patient harm, misuse and criminality.
These regulations require NHS England and other ‘designated bodies’ such as NHS trusts and independent hospitals to appoint Accountable Officers for Controlled Drugs, and requires those Accountable Officers to ensure safe systems are in place for the management and use of controlled drugs.
The Accountable Officer for NHS England covering Cornwall and the Isles of Scilly, Devon, Dorset, Somerset, Bristol, North Somerset, and South Gloucestershire is Jon Hayhurst who can be contacted via firstname.lastname@example.org and his team will respond to any query about the safe use of controlled drugs.
The Accountable Officer for NHS England covering Bath & North East Somerset, Gloucestershire, Swindon, and Wiltshire is Julie McCann who can be contacted via england.southcentral-CD@nhs.net and her team will respond to any query about the safe use of controlled drugs.
Reporting of incidents involving controlled drugs
All incidents involving controlled drugs should be reported to the Accountable Officer. This provides assurance that any risks have been mitigated, and prompts any action to be taken if they are not. Reporting also allows for the identification of themes in reported incidents from which learning can take place.
We strongly advocate a ‘Just Culture’ in which healthcare staff are supported to be open about mistakes to allow valuable lessons to be learnt so the same errors can be prevented from being repeated. We help people to investigate, the reflect, to learn and to take action to prevent a recurrence.
Staff in organisations that do not have their own Accountable Officer should report their incidents to the accountable officer at NHS England. You can do this online at www.cdreporting.co.uk.
We share the learning from incidents reported to us and update on relevant topics via our local intelligence networks and via newsletters.
Local Intelligence Networks
The regulations require the NHS England Accountable Officer to facilitate a ‘Local Intelligence Network’ to share information and intelligence about the misuse and unsafe use of controlled drugs. The membership is comprised of Accountable Officers of designated bodies, colleagues from the Care Quality Commission, Counter Fraud, Police Force and the General Pharmaceutical Council, as well as colleagues from Clinical Commissioning Groups, Local Authorities, and providers of healthcare that are not designated bodies.
The local intelligence network in the South West meets twice a year in five locations: Bristol, Bodmin, Exeter, Saltash, and Taunton.
Organisations that do have their own Accountable Officer (designated bodies) are required to send a summary of their controlled drugs incidents in an ‘occurrence report’ to the accountable officer at NHS England every three months. You can do this online at www.cdreporting.co.uk.
Lawful destruction of controlled drugs
Controlled drugs in schedules 2, 3, and 4 (part 1) must be denatured before being disposed of. Healthcare staff that are lawfully in possession of these can do so, but should ensure they have a ‘T28 exemption’ from the Environment Agency that allows this. All denaturing should be witnessed by another person, and in the case of stocks of schedule 2 controlled drugs it must be witnessed by a person authorised by an Accountable Officer. You can request an authorised witness online at www.cdreporting.co.uk.
Private prescribing of schedule 2 and 3 controlled drugs
Amendments to the Misuse of Drugs Regulations 2001 require private prescriptions or requisitions for medicines containing schedule 2 and 3 controlled drugs to be issued on controlled stationery bearing a unique prescriber identification number (PIN).
You can obtain a new PIN, or make changes to your PIN record (such as name and address) by contacting the Accountable Officer via email@example.com.
If you have a PIN and need to order controlled stationery for prescribing you can obtain this from Primary Care Support England via their website.
If you wish to obtain rather than prescribe controlled drugs and have a PIN you can download the mandatory FP10CDF form for this here.
Declarations and self-assessments of compliance with the regulations by NHS commissioned primary care contractors
The regulations require us to seek periodic confirmation from NHS commissioned primary care contractors such as medical and dental practices that they practice in accordance with the regulations. This is requested periodically and can be submitted online at www.cdreporting.co.uk.
Safer Management of Controlled Drugs: Annual Report 2017/18
The NHS England South West Controlled Drugs team published their 2017/18 Annual Report on 28 August 2018. You can download a copy of the report here. We welcome feedback. Contact us at firstname.lastname@example.org
Please contact us if you require any advice or support, or have any further queries about the safe use of controlled drugs. Our secure email address is email@example.com.